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10,032 catalysts · 3,312 8k filing · 2,079 grant · 1,097 approval · 1,000 device adverse event · 800 device 510k · 584 earnings
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10,032 catalysts · 3,312 8k filing · 2,079 grant · 1,097 approval · 1,000 device adverse event · 800 device 510k · 584 earnings
Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Product code: LOX. Advisory committee: Cardiovascular. Type: Traditional
Product code: JXI. Advisory committee: Neurology. Type: Traditional
NS grant. $120,582. PI: Kiah Hardcastle
Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: MYLAN. Form: TABLET. Route: ORAL
Sponsor: AMTA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: DSA. Advisory committee: Cardiovascular. Type: Special
CA grant. $87,964. PI: Katherine Ismei Zhou
Sponsor: HQ SPECLT PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: HQ SPECLT PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
AR grant. $15,000. PI: JOY Y WU
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ALKEM LABS LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL
Sponsor: BAUSCH AND LOMB. Form: GEL. Route: OPHTHALMIC
Sponsor: UMEDICA. Form: CAPSULE. Route: ORAL
Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: TABLET. Route: ORAL
Sponsor: APPCO. Form: CAPSULE. Route: ORAL
Product code: HHW. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: DWF. Advisory committee: Cardiovascular. Type: Special
Product code: FBN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: EZL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: KPR. Advisory committee: Radiology. Type: Traditional
Product code: QEY. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: APPR
GEM Premier 5000 PAK, Part No. 00055360004. — Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. — Status: Ongoing
GEM Premier 5000; Part No. 00055415005. — Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. — Status: Ongoing
GEM Premier 5000; Model No. 00055430010. — Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. — Status: Ongoing
GEM Premier 5000; Part No. 00055430008. — Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. — Status: Ongoing